MAUDE Adverse Event Report: BECTON DICKINSON BD CATHENA 20GX1.25INSTRAIGHT BC; INTRAVASCULAR CATHETER

Catalog Number	386804
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd cathena 20gx1.25instraight bc catheter defective / damaged one of our clinical xxxxx had an issue inserting a bd cathena pivc today.It was a 20ga, lot number 4178013, expiry 30/06/2027.On insertion into the vein the spring caused the sharp to forcefully eject and it landed on the floor, the spring remained in the catheter and therefore the pivc was removed as it could not be used correctly.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
Based on device history record review, no abnormality was observed during the production of the affected batch.As current control, there is in-process visual inspection to check for catheter tubing and adapter damage.There is functional test in place for system penetration and catheter drag functional test that can detect cannula tip and catheter damage.In addition, there is functional test in place to check for catheter to adapter pull force.As no photo/sample is returned for evaluation, actual root cause could not be established.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Becton dickinson and company's (bd) medication delivery solutions (mds) business unit will discontinue malfunction mdr reporting for certain device failures that have not caused or contributed to deaths or serious injuries in the past two years, and where the likelihood of a death or serious injury as a result of these malfunctions is remote.This decision follows fda guidelines (medical device reporting for manufacturers guidance for industry and food and drug administration staff issued nov 8, 2016, reference section 2.15).Bd notified fda of this decision on mar 3, 2025.Fda has reviewed and responded to bd¿s notification (reference fda document # (b)(4)) on march 7, 2025.This documentation is available in bd document management system (sap) as dir (b)(4).This supplemental mdr is being filed to document that the below device failure will no longer be considered a reportable malfunction mdr for the product family below: product family: cathena.Device failure: connection issues.

• Brand Name: BD CATHENA 20GX1.25INSTRAIGHT BC
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 20730087
• Report Number: 2243072-2024-01144
• Device Sequence Number: 8977127
• Product Code: FOZ
• UDI-Device Identifier: 00382903868049
• UDI-Public: (01)00382903868049(11)240403(17)270331(10)4082697
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K172506
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/29/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 386804
• Device Lot Number: 4082697
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2024
• Supplement Date Received by Manufacturer: 12/02/2024; Not provided
• Initial Report FDA Received Date: 11/19/2024
• Supplement Report FDA Received Date: 12/11/2024; 04/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/03/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown